Pradaxa – Stroke Prevention in Atrial Fibrillation

Analysis posted October 2013

Our analysis shows Pradaxa (dabigatran) to have high Clinical Innovation over warfarin as the previous SOC for preventing stroke in patients with atrial fibrillation (AF). The “Drivers of Improvement” graphic below summarizes the results of our analysis:

Warfarin’s total unmet need score in AF is 1.23, the yellow bar on the left side of the graphic

Dabigatran’s unmet need score is 1.04, the yellow bar on the right side of the graphic

Drivers of Improvement

A small advantage in safety/side effects (less monitoring required and fewer drug-drug interactions)

A slight disadvantage in dosing (BID vs. QD)

Dabigatran’s higher cost diminishes its innovation score, but its net Clinical Innovation of nearly 16% is still high compared with historical norms. As our model predicts, dabigatran has performed well in the AF market since its launch in late 2010.

Following dabigatran’s launch, several other competitors entered the AF market. Rivaroxiban (Xarelto) was approved for this indication about a year after dabigatran, with similar Clinical Innovation relative to warfarin (with somewhat different strengths and weaknesses to those of dabigatran). Rivaroxiban has also competed effectively in this population. In early 2013, apixaban (Eliquis) was also approved, and again it has a similar level of Clinical Innovation compared with warfarin.All three of these drugs offer substantial improvement over warfarin, and we expect that they will, collectively, dominate this market. However, we do not expect apixaban to achieve as high a patient share, due to its later market entry. For instance, if dabigatran is considered as the new SOC, then apixaban has minimal Clinical Innovation.

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Interpreting the “Drivers of Improvement”

This graphic depicts the advantages and disadvantages of a new drug, compared
with the current standard of care (SOC). The yellow column on the left represents
unmet need for patients treated with the SOC; the yellow column on the right,
unmet need under the new drug. The new drug’s reductions in unmet need (i.e.
improvements) are shown as green boxes; its disadvantages are shown in red.